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BioWave Corp., the Norwalk, CT manufacturer of neurostimulation devices for treating pain, offers a variety of FDA-cleared medical devices, all based on its patented, high-frequency neurostimulation technology for non-opioid, long lasting pain relief. The company’s products include BioWavePRO, for use in a hospital, physician’s office, or athletic training environment, and BioWaveHOME, a home prescription portable version.

BioWave devices are in use by physicians nationwide, including at more than 80 VA Hospitals as well as by more than 120 professional sports teams across the NFL, NHL, NBA, MLB, and 160 major NCAA sports programs. BioWave has also been officially recommended by Vietnam Veterans of America.

BioWave’s “Blue Box” therapy delivers neurostimulation pain relief using two sinusoidal high-frequency AC signals through the skin into deep tissue to block pain including nociceptive pain fibers. The treatment provides functional improvement including a greater range of motion and a reduction in stiffness and muscle spasm for up to 72 hours with percutaneous electrodes and for up to 24 hours with noninvasive electrodes following a 30-minute treatment.

BioWavePRO, the company’s first device to enter the market, is a rugged hand-held device for clinical use only. The battery capacity is designed to administer 18 30-minute treatments within one day. BioWavePENS is an FDA-cleared percutaneous system. The 1000 needle electrodes are 2.5 in. in diameter and are sterile, single-use. The device is used to treat nociceptive and neuropathic pain. BioWaveHOME offers the same output as the BioWavePRO; however it is a smaller device with the battery capability of four 30-minute treatments with a single charge.

The device includes a simple LED screen but requires no programming. BioWavePRO and BioWaveHOME use surface electrodes. All of the devices require a prescription. BioWaveGo is a new OTC device with an anticipated launch by the end of 2018. It also delivers high-frequency-nerve stimulation in 30-minute sessions. The wearable, Bluetooth-enabled technology interacts with a smartphone app.

“Healthcare is moving into the home,” said BioWave founder and president Brad Siff in an interview with NBR. “The launch of the new BioWaveGO OTC device is the evolution of bringing an established therapeutic technology to the public for the treatment of chronic and acute pain.”

BioWave investigators published results of a randomized double-blinded comparative crossover study of their therapy vs. traditional TENS in the journal Pain in 2006. In 2007, they published pilot study results in Orthopedics of their percutaneous therapy for patients with knee OA. For the post-op knee replacement surgery, the treatment group reduced morphine use by almost one-half compared to the control group. In a VA-study, the treatment group experienced a 58 percent reduction in the use of pain medications when compared to the sham cohort. In three studies, the treatment group experienced a significant reduction in opioid use.

BioWave says that its patented technology is now in use at more than 80 U.S. Department of Veterans Affairs medical centers nationwide. This includes eight of the 19 VA Centers of Innovation, which lead the charge in specific areas of patient care. “As the opioid epidemic continues to rage and with new laws around prescription pain medications it is more important than ever that our veterans have access to a non-opioid, non-addictive effective technology like BioWave,” said Rob Wolter, CEO. “We are encouraged by the willingness and leadership on behalf of VA health professionals to embrace BioWave to help veterans obtain our non-opioid and effective tool to help manage and block chronic or acute pain.”

Siff said that the company’s revenue model differs from other players in this space. Payer channels include worker’s compensation, VA medical centers/active duty military, sports/athletic teams, and private insurers. The company’s BioWave360 program is targeted toward pain and spine clinics and worker’s comp cases. The company will pre-authorize the BioWaveHOME unit, a six-pack of PENS electrodes, and a 20-pack of surface electrodes. They will invoice worker’s comp and ship the order directly to the clinician. The clinician provides six treatments using the PENS electrodes and then sends the device and the surface electrodes home with the patient.

With the medical model, the company offers a free trial of the device for the physician, who then recommends a home unit. BioWave is now closing contracts with private insurers such as Aetna and Cigna for clinical treatment with the BioWavePRO and then BioWaveHOME devices for long-term patients. With the exception of doctor’s offices, approximately 75 percent of the company’s revenue is from the sale of the units while 25 percent of the revenue is from the sale of electrodes. In the doctor’s offices, the majority of the revenue is from the sale of PENS.

Siff, BioWave founder and president, currently manages new product and clinical development, reimbursement, regulatory, and marketing/contract manufacturing. He earned an MBA and M.S. in engineering from Cornell University. Previously he was senior vice president of M&A for Daiwa Securities. CEO Rob Wolter joined BioWave in 2016 and manages the business operations.

In 2016, BioWave closed a Series D funding of $1.6 million They doubled revenue from 2016 to 2017. The company is seeking a new round of capital to fuel the expansion of sales and marketing including a direct outside sales team, and to help launch BioWaveGO.